欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2279/003
药品名称
Lesamor
活性成分
hydrochlorothiazide 25.0 mg
telmisartan 80.0 mg
剂型
Tablet
上市许可持有人
Stada Arzneimittel AG Stadastrasse 2-18 61118 - Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
Lesamor
互认成员国 - 产品名称
许可日期
2013/11/14
最近更新日期
2023/12/04
药物ATC编码
C09DA07 telmisartan and diuretics
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Additional Strength/Form
TypeLevel3：
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final SPC
|
Lesamor Common SmPC _ clean
Date of last change:2023/01/26
Final PL
|
Lesamor Common PIL _ clean
Date of last change:2022/11/04
Final Labelling
|
1.3.1-LABcomb-COM-TelmHCT2279-Var005-CLEAN
Date of last change:2019/01/11
Final Product Information
|
1.3.1-SPC-COM-TelHCT-2278-V004D30-cl
Date of last change:2018/03/15
Final Product Information
|
1.3-LABcomb-TelmHCT2278-Var004-cl (1)
Date of last change:2018/03/15
Final Product Information
|
1.3.1-SPC-COM-TelHCT-2279-V003D30-clean
Date of last change:2018/03/15
Final Product Information
|
1.3-LABcomb-COM-TelmHCT2279-Var003-cl
Date of last change:2018/03/15
Final Product Information
|
1.3-PIL-COM-TelHCT-2279-V003-cl
Date of last change:2018/03/15
Final Product Information
|
1.3-PIL-COM-TelmHCT2278-Var004-cl
Date of last change:2018/03/15
PAR Summary
|
sPAR%20Telmisartan+HCT%20DK_H_2279[1]
Date of last change:2015/02/03
PAR
|
Final PAR Scientific discussion Lesamor DKH2279_001-003_DC
Date of last change:2014/11/18
市场状态
Positive
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